Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-4
Summary
The FDA issued a Class II for Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packa by Vi-Jon, LLC. Reason: Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol..
Details
Source
Drug Recall
External ID
D-1244-2022
Action Date
2022-07-27
Status
Terminated
Category
drug
Product Description
Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC Quality Choice UPC 6 35515 99466 9 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd, Novi, MI; d) CVS Health UPC 0 50428 37591 4 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; e) Careone UPC 3 41520 31311 0 Distributed By: Foodhold U.S.A., LLC Landover, MD 20785; f) Market Basket UPC 0 49705 75280 7 Distributed By Demoulas Super Markets, Inc. 875 East Street, Tewksbury, MA 01876; g) Rexall UPC 0 72785 13848 3 Distributed By Old East Main Co. 100 Mission Ridge, Goodlettsville, TN 37072; h) HEB UPC 9 41220 25111 7 Distributed By: HEB San Antonio, TX 78204; i) Core Values UPC 0 79068 00707 8 Distributed by Liberty Procurement Co., Inc. Union, NJ 07083; j) Swan NDC 0869-0871-43 UPC 3 08694 70610 0 Distributed by Vi-Jon One Swan Drive, Smyrna, TN 37167; k) Cariba Care UPC 6 46702 05602 2 Distributed by: Cariba International P.O. Box 1208. Safety Harbor, Florida 34695; l) Kroger UPC 0 11110 79460 4 Distributed By The Kroger Co., Cincinnati, Ohio 45202; m) CVP Health UPC 7 61706 16314 6 Distributed By Salado Sales, Inc. Temple, TX 76503; n) Medline NDC 53329-981-06 UPC 0 80196 74870 2 Made in US with US and foreign components for Medline Industries, Inc., Northfield, IL 60093; o) Exchange Select UPC 6 14299 39968 6 Manufactured For Your Military Exchanges By: Vi-Jon 8515 Page Avenue, St. Louis, MO 63114; p) Premier Value UPC 8 40986 01021 7 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087; q) Publix UPC 0 41415 00973 8 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway Lakeland, FL 33811; r) Being Well UPC 0 51933 13950 3 Distributed By: Moran Foods, LLC St. Ann, MO 63074; s) Medicare NPN 80016265 UPC 8 39748 00017 7 Manufactured by/Fabrique par: Vi-Jon Inc., Smyna, TN 37167; t) Swan NPN 80035214 UPC 0 72785 11239 1 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; u) Equate NPN 80036214 UPC 6 28915 16613 3 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; v) Iris UPC 61504-871-43 UPC 0 41512 12940 7 Distributed By: Amerifoods Trading Co. P.O. Box 512377, Los Angeles, CA 90051-0377; w) Equaline NDC 41163-871-43 UPC 0 41163 25134 2 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA; x) TopCare health UPC 0 36800 26711 4 Distributed By TopCo Associates LLC Elk Grove Village, IL 60007; y) Best Choice UPC 0 70038 20055 0 Distributed By: Valu Merchandisers, Co. 6000 Kansas Ave. Kansas City, KS 66106; z) Walgreens NDC 0363-0871-43 UPC 3 11917 20771 1 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015; aa) Equate NDC 49035-871-43 UPC 6 81131 11871 2 Distributed By: Walmart, Inc., Bentonville, AR 72716
Lot/Code Info: Lots: 0555123 Exp. 11/2023 ; 0556347 Exp. 01/2024 ; 0559888 Exp. 03/2024 ; 0546090 Exp. 09/2023 ; 0546364 Exp. 08/2023 ; 0554099 Exp. 11/2023 ; 0535281 Exp. 05/2023 ; 0538263 Exp. 07/2023 ; 0542015 Exp. 07/2023 ; 0550161 Exp. 10/2023 ; 0550164 Exp. 11/2023 ; 0556345 Exp. 01/2024 ; 0557214 Exp. 12/2023 ; 0557366 Exp. 01/2024 ; 0568635 Exp. 05/2024 ; 0556328 Exp. 11/2023 ; 0557465 Exp. 03/2024 ; 0566639 Exp. 03/2024 ; 0566835 Exp. 03/2024 ; 0538261 Exp. 06/2023 ; 0538264 Exp. 07/2023 ; 0541465 Exp. 07/2023 ; 0556809 Exp. 11/2023 ; 0566640 Exp. 03/2024 ; 0556351 Exp. 01/2024 ; 0563077 Exp. 02/2024 ; 0564653 Exp. 03/2024 ; 0565511 Exp. 04/2024 ; 0566646 Exp. 03/2024 ; 0532595 Exp. 04/2023
Quantity Affected: 3,421,032 bottles
Reason for Recall
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Distribution
Nationwide in the USA and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-28
Company
Smyrna, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Vi-Jon, LLC has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vi-Jon, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vi-Jon, LLC have FDA actions?
Vi-Jon, LLC has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1244-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22